Kornimate/medical-research-clean huggingface dataset:
formulas for diabetes with sucromalt & isomaltulose on glycemic index, hormones & subjective appetite in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: consumption of nutritional supplements with low glycemic carbohydrates induce favorable glycemic responses in subjects with type 2 diabetes. the aim of this study was to compare the effect of the intake of specific formulas for diabetes, with different types of carbohydrates (isomaltulose and sucromaltose) on the glycemic response, release of intestinal peptides and subjective appetite in type 2 diabetic individuals. in a randomized, double-blind, cross-over study of 4 treatments, 16 subjects (56.60 ± 1.11 years). fasting blood samples were taking, after that they were given to consume formula or reference product assigned randomly. subsequently, samples of capillary and venous blood were obtained at times 30, 60, 90, 120 and 180 min, after the start of consumption of the experimental beverage for the measurement of glucose, insulin, gastric inhibitory peptide (gip) and glucagon-like peptide-1 (glp-1). the assessment of subjective appetite was measured by visual analogue scale (vas).

this was a randomized, double-blind, cross-over study of 4 treatments that was conducted according to the good clinical practice guidelines, with all applicable food and drug privacy regulations, and ethical principles based on the declaration of helsinki. participants signed informed consent, approved by the human research ethics committee of the endocrine-metabolic research center of the university of zulia, in venezuela. all selected subjects attended a first visit, in order to determine if they met the inclusion criteria, those who gathered them, were subjected to four consumption tests to determine the glycemic index (gi) and glycemic load (gl) and 3 consumption tests for the evaluation of subjective appetite. each treatment or consumption session was carried out on different days.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * demonstrated use of oral hypoglycemic agents (metformin), for at least two months * bmi of 18.5 kg/m2 to ≤ 35 kg/m2 exclusion criteria: * type 1 diabetes * diabetic ketoacidosis * congestive heart failure * gastric, renal or hepatic diseases * myocardial infarction * stroke * subjects with insulin therapy, antibiotic therapy or corticosteroids * end-stage organ failure * individuals with organ transplantation * coagulation or bleeding disorder * infectious or chronic contagious disease (such as tuberculosis, hepatitis b or c or hiv).

Keywords: glycemic index insulin incretins diabetes mellitus type 2 subjective appetite nutritional formula
effect of acp-501 on safety, tolerability, pharmacokinetics and pharmacodynamics in subjects with coronary artery disease

Conditions: Coronary Artery Disease; Atherosclerosis

Summary: this study is a phase 1, intravenous, open-label, single-dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of acp-501 (recombinant human lecithin cholesterol acyl transferase (rhlcat)) in subjects with coronary artery disease (cad). four cohorts consisting of 4 subjects each will receive one dose of acp-501. the dose will be escalated by cohort.

after signing informed consent, subjects entered into the trial will be followed for up to 8 weeks which includes: up to 4 weeks screening, entry criteria assessments on day 0 and single-dose iv infusion on day 1, and 4 weeks of follow-up.

Eligibility criteria:
inclusion criteria: * a history of stable documented cad * currently non-smoking males and females ages 30 to 85 years inclusive. o female subjects of child-bearing potential (neither pregnant nor breast-feeding) must be using adequate birth control during study conduct. * chronic concomitant medications must be stable for at least 2 months prior to screening * hdl-c \< 50 mg/dl for men and \< 55 mg/dl for women * body mass index (bmi) of approximately 18 to 35 kg/m\^2; and a total body weight \>= 50 kg (110 lbs) and \<= 110 kg (approximately 242 lbs) exclusion criteria: * myocardial infarction, stroke, or coronary intervention/revascularization procedure within 6 months prior to dosing. * chronic heart failure (\> new york heart association (nyha) functional classification ii). * ventricular tachyarrhythmias. * uncontrolled type 2 (hba1c \> 8.5%) or type 1 diabetes mellitus. * history of febrile illness within 5 days prior to dosing. * history of regular alcohol consumption exceeding 10 drinks per week. * 12-lead ecg demonstrating qtc \> 500 msec at screening. * other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.

Keywords: lecithin cholesterol acyl transferase lcat rhlcat enzyme replacement therapy high-density lipoprotein (hdl) cholesterol cholesterol ester lcat deficiency
a comparison between ebus-gs and ct-guided lung biopsy in diagnosis of peripheral pulmonary lesions.

Conditions: Lung Neoplasms

Summary: this is a randomized controlled trail aiming at comparing the diagnostic value and safety of endobronchial ultrasonography with a guide sheath(ebus-gs) and computed tomography-guided transthoracic needle biopsy(ct-ttnb) for peripheral pulmonary lesions (ppls). patients eligible for the inclusion criteria are diagnosed using either ebus-gs or ct-ttnb randomly. the diagnostic indicators such as sensitivity, specificity, and accuracy are compared between the two groups. post-procedure complications are recorded.

ct-ttnb is widely used in the diagnosis of ppls and its sensitivity for lung cancer remains as high as 90%. however, the relatively high rate of complications such as pneumothorax, hemoptysis, pulmonary hemorrhage, severe chest pain, and bad tolerance in patients limits its application. ebus-gs is an emerging technology, kurimoto in 2004 performed transbronchial lung biopsy(tblb) assisted by ebus-gs, and the sensitivity of diagnosing lung cancer was 81%, and it was proved to be a safe procedure with very small amount of pneumothorax and hemoptysis. till now there is only one randomized controlled study comparing the diagnostic value of ct-ttnb and ebus-gs; however, it did not complete the enrollment of patients on schedule. in addition, all the other studies were retrospective. hence this prospective study was performed to determine the diagnostic value and safety of ebus-gs and ct-ttnb for ppls.

Eligibility criteria:
inclusion criteria: * lesions presented as nodule or mass in ct imaging and located at the distal end of the segmental bronchus; invisible under normal bronchoscope; no pathological results were obtained before biopsy procedure; patients can tolerate video assisted thoracic surgery(vats) lobectomy or wedge resection; all patients provided written informed consent. exclusion criteria: * presence of central pulmonary lesion and visible under the bronchoscope; lesions presented as exudative or consolidation in ct imaging; the location was unsuitable for ct-guided biopsy; presence of pneumothorax or pleural effusion patients have contraindication for ebus-gs or ct-ttnb,such as cardiopulmonary dysfunction, cachexia, thrombocytopenia or coagulopathy.

Keywords: endobronchial ultrasonography guided sheath diagnosis accuracy complication
a phase 1, first-in-human study of vx-668

Conditions: Alpha-1 Antitrypsin Deficiency

Summary: the purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (pk) of vx-668 at various doses.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * participants of age between 18 to 55 years (inclusive) * body mass index (bmi) of 18.0 to 32.0 kilogram per meter square (kg/m\^2) * a total body weight of more than (\>)50 kg * nonsmoker or ex-smoker for at least 3 months before screening key exclusion criteria: * any condition possibly affecting drug absorption * females of childbearing potential other protocol defined inclusion/exclusion criteria may apply.
vitamin d supplementation in rna-seq profiles of single-core prostate samples, among veterans

Conditions: Prostate Cancer; Vitamin D Deficiency; Stress Reaction

Summary: veterans between the ages of 50-75, who are having a prostate biopsy, will be recruited for their permission to collect an extra biopsy core for rna-sequencing. if the participants' treatment decision is active surveillance, they will be enrolled into the intervention phase of the study. they will receive supplementation with vitamin d3 (4,000 iu) daily with repeat (surveillance) prostate biopsy one year later. at that time an extra prostate sample core will be collected for rna-sequencing to determine changes over time. measurements for allostatic load (body stress/inflammatory markers) will also be collected at the time of enrollment and at the repeat prostate biopsy visit.

this is an open-label pilot study. the goal is to investigate the transcription and biological pathways in prostate cancer that are especially relevant to prostate cancer disparities between african american and caucasian men. also, to determine any significant differences in the molecular signature that exist in african american and caucasian men in relation to their vitamin d levels. recruitment will be at the urology clinic at the ralph h. johnson va medical center in charleston, sc. men who are scheduled for a standard of care prostate biopsy will be consented for their permission to collect an extra prostate tissue core for rna-sequencing. after the pathology report is discussed by their urologist, and the treatment decision is active surveillance, the participant is enrolled into the intervention phase. at that time, baseline allostatic load measurements (blood pressure, pulse, waist/hip ratio, height, and weight for bmi) and bloodwork: (lipid panel, hgba1c, albumin and creatinine, il-6, crp, and dhea-s (inflammatory markers) plus a vitamin d level, will be collected. vitamin d3 soft gels (4,000 iu) daily (six months' supply) will be dispensed. a social determinants survey will also be dispensed for subject completion. at the urology standard of care six-month follow-up appointment, the vitamin d serum level will be collected and the next six months' supply of vitamin d3 will be dispensed. at the urology standard of care follow-up (repeat at 1 year) surveillance prostate biopsy, an extra prostate tissue core will be collected for rna-sequencing. the allostatic load measurements and bloodwork will also be obtained.

Eligibility criteria:
inclusion criteria: recruitment: * scheduled for prostate biopsy * permission for investigators to follow subject's post biopsy diagnosis, treatment decision and follow-up care (including subsequent prostate biopsies). enrollment: * diagnosis of prostate cancer * treatment recommendation or subject decision of active surveillance * agreement to supplement with vitamin d3 4,000 iu daily for approximately one year * standard of care repeat psa at six months and surveillance prostate biopsy at one year exclusion criteria: * current vitamin d3 supplementation \> 2,000 iu daily * inability or unwillingness to continue to participate in the study
effect of large volume paracentesis on fatigue in cirrhosis

Conditions: Ascites; Fatigue; Cirrhosis

Summary: the purposeof this study is to determine the effect of a large volume paracentesis (procedure in whihc a catheter is placed to remove fluid from the abdomen) on the severity of fatigue i patients with cirrhosis (severe scarring of the liver) and large volume ascites (fluid in the abdomen).


Eligibility criteria:
inclusion criteria: * ambulatory patient with cirrhosis * baseline cr \<2 * ability to complete psychometric testing * refractory ascites exclusion criteria: * cr \>2 * history of gastrointestinal bleed * history of infection * history of renal failure

Keywords: quality of life
hepatitis b research network pediatric cohort study (hbrn)

Conditions: Hepatitis B

Summary: the purpose of this study is to describe participants 6 months to \<18 years of age with hepatitis b virus (hbv) infection in a prospective cohort in the united states (us) and canada and identify predictors of disease activation and progression.

•primary aim: o to describe participants 6 months to \<18 years of age with hepatitis b virus (hbv) infection in a prospective cohort in the united states (us) and canada and identify predictors of disease activation and progression secondary aims: * to describe clinical, virological, and immunological characteristics of participants with hbv in the us and canada. * to evaluate changes in hbv infection status and hepatitis b surface antigen (hbsag) levels and factors associated with those changes. * to verify whether a baseline hbsag below 1,000 iu/ml and hbv dna below 1,000 iu/ml is an accurate predictor of people who are, or who will become, inactive carriers, defined as people who are hbsag positive, hepatitis b "e" antigen (hbeag) negative, have normal alanine aminotransferase (alt) and hbv dna under 1,000 iu/ml on at least two occasions over a period of at least 6 months with hbv dna under 1,000 iu/ml. * to assess the health related quality of life (hrqol) of treatment naïve hepatitis b surface antigen (hbsag) positive children and adolescents * to develop a bank of biospecimens (e.g., serum, plasma, dna, liver tissue) obtained from participants with hbv infection. * to identify pediatric participants from 2 years to \<18 years of age with chronic hbv infection for potential participation in treatment study to be conducted by the hepatitis b research network (hbrn).

Eligibility criteria:
inclusion criteria: * written informed consent/assent as appropriate * at least 6 months to \<18 years of age * hepatitis b surface antigen (hbsag) positive exclusion criteria: * hepatic decompensation * hepatocellular carcinoma (hcc) * liver transplantation * current hepatitis b antiviral treatment (except pregnant females) * known coinfection with hiv (patients with hepatitis d or hepatitis c coinfection are not excluded) * medical or social condition which in the opinion of the principal investigator would interfere with or prevent regular follow up. * unable or unwilling to return for regular follow-up

Keywords: hepatitis b hbv pediatric
the effect of aromatherapy massage on sleep quality

Conditions: Diabetes Mellitus; Respiratory Failure; Pneumonia; Respiratory Disease; Stroke, Ischemic

Summary: sleep disturbance is one of the most common complaints of patients admitted to icu. insufficient sleep in intensive care units may be associated with environmental reasons such as excessive light at night, loud warning sounds and mechanical ventilation alarms, as well as non-environmental factors, including the situation at the time of admission. sleep assessment is subjective in nature, so it is difficult to perform in the icu. since communication with the patient is prevented, clear information about perceived rest and disturbing factors cannot be provided. for this reason, night rest is an issue that is often forgotten and ignored. this study applied a mixture of lavender, medicinal chamomile and neroli oil (in 20 ml of sweet almond oil; lavender oil 2 drops, medicinal chamomile 4 drops, neroli oil 6 drops) to patients who were monitored in intensive care on high-flow and oxygen, once a day for three days. this study will be conducted to determine the effect of aromatherapy massage applied for a total of 30 minutes on sleep quality.


Eligibility criteria:
inclusion criteria: * 18 years of age and over, * conscious patients, * staying in intensive care for 24 hours or more, * those with stable hemodynamic status, * receiving o2 therapy, * intubated patients, patients who have passed 24 hours after being extubated, * those whose saturation level is 85 and above exclusion criteria: * patients with peripheral neuropathy or quadriplegia, * patients with open wounds on their body, * patients receiving analgesia and sedation infusion, * patients who are sedated, * patients in delirium, * patients with allergies detected before starting the application

Keywords: intensive care sleep quality aromatherapy massage
effects of etanercept on nail psoriasis and plaque psoriasis

Conditions: Nail Psoriasis; Plaque Psoriasis

Summary: the purpose of this study is to evaluate if etanercept administered at a higher initial dose provides greater improvement in nail and skin psoriasis symptoms than a regimen with a lower initial dose.

this study will assess the effects of the 2 etanercept regimens on fingernail psoriasis over 24 weeks among patients with both skin and fingernail symptoms who have previously failed at least one therapy for nail psoriasis. the endpoint of 24 weeks was chosen to allow sufficient time for normal nail growth.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * active, stable plaque psoriasis defined by the following criteria: * body surface area (bsa) ≥ 10 % at screening and baseline * or, pasi \>10 at screening and baseline * or, pga of psoriasis status of moderate or worse (moderate, marked, or severe) at screening and baseline * or, dlqi \> 10 at baseline * active fingernail psoriasis defined as target fingernail napsi ≥ 2 and overall napsi \> 14 - target nail is defined as the nail with the highest nail score (matrix+bed scores) at baseline. should more than one fingernail have the same score, the target fingernail will be chosen by the investigator. * failure of at least one systemic psoriasis therapy for nail psoriasis * eligible to receive biologic therapy for psoriasis in accordance to local guidelines exclusion criteria: * evidence of skin conditions other than psoriasis * psoralen plus ultraviolet radiation (puva), cyclosporine, alefacept, methotrexate, acitretin, or any other systemic anti-psoriasis therapy within 28 days of study drug initiation * prior exposure to any tnf-inhibitor. prior exposure to efalizumab

Keywords: nail psoriasis plaque psoriasis
vitamin k to attenuate coronary artery calcification in hemodialysis patients

Conditions: End-stage Kidney Disease

Summary: the purpose of this study is to see if vitamin k supplementation three times per week reduces the progression of coronary artery calcification over 12 months in dialysis patients compared to placebo.

at every stage of chronic kidney disease (ckd), the leading cause of mortality is cardiovascular disease. this is due, in part, to vascular calcification (vc) of the coronary arteries. the extent of vc in the coronary arteries of patients with ckd is commonly determined by high resolution ct scan. the total coronary artery calcium (cac) score, measured in agatston units (aus), reflects the calcium burden in the three major coronary arteries and is the current standard for determining extent of vascular calcification in hemodialysis patients. matrix gla protein (mgp), a vitamin k dependent protein, is a key inhibitor of vascular calcification and is present in the arterial wall. it is established that mgp becomes up-regulated adjacent to sites of calcification and that vitamin k is critical to its function. therefore vitamin k status may be critical to the extent of vascular calcification in this patient group. however, to date, no trial has examined whether vitamin k supplementation prevents the progression of coronary artery calcification in patients with kidney failure, a group in which high risk has been established. therefore, our primary research question is: does vitamin k supplementation with 10 mg of phylloquinone thrice weekly reduce the progression of coronary artery calcification (as measured by cac score) over 12 months in prevalent hemodialysis patients with a baseline cac score of ≥ 30 agatston units compared to placebo?

Eligibility criteria:
inclusion criteria: * able to provide signed informed consent * ≥18 years of age * expected to survive one year * have end-stage kidney disease and require hemodialysis * have a baseline coronary artery calcification score ≥30 agatston units (aus) exclusion criteria: * have a medical condition that requires warfarin * require hemodialysis for acute kidney injury * are pregnant * have other severe co-morbid conditions (e.g. malignancy, disabling stroke) with life expectancy less than one year * have undergone coronary artery bypass grafting or have stents placed in their coronary arteries * are currently enrolled in another interventional trial

Keywords: vitamin k chronic kidney disease vascular calcification hemodialysis coronary artery calcification
home blood pressure monitoring trial

Conditions: Stroke; Ischemic Attack, Transient

Summary: design: community based randomised trial with follow up after 12 months participants: 360 patients admitted with stroke or tia within the past 9 months will be recruited from the wards or outpatients and randomly allocated into two groups. all patients will be visited by the specialist nurse at home at baseline when she will measure their bp and administer a questionnaire. the questionnaire and bp will be repeated at 12 months follow-up by another researcher blind as to whether the patient is in intervention or control group. intervention: intervention patients will be given a validated home bp monitor and support from the specialist nurse. control patients will continue with usual care (bp monitoring by their practice). main outcome measures in both groups after 12months: 1.change in systolic bp 2.cost effectiveness: incremental cost of the intervention to the nhs and incremental cost per quality adjusted life year gained. study hypothesis. home blood pressure monitoring with nurse support wil lead to lower blood pressure after 12 months compared with usual gp care

high blood pressure in patients with stroke increases the risk of recurrence but management in the community is often inadequate. home blood pressure monitoring may increase patients' involvement in their care, increase compliance, and reduce the need for patients to attend their gp if blood pressure is adequately controlled. however the value of home monitoring to improve bp control is unclear and there is now a window of opportunity for evaluation before their use becomes widespread in the uk. furthermore its use in stroke patients presents unique challenges relating to the consequent neurological disability.

Eligibility criteria:
inclusion criteria: * stroke or tia in last 9 months * blood pressure above 140/85 when measured more than 1 week after stroke or on anti hypertensive medication exclusion criteria: * severe illness likely to dominate pattern of care * already using home blood pressure monitor * non-english speaking * severe cognitive impairment (amts\<7) * known secondary hypertension

Keywords: home monitoring primary care hypertension tia